Patients' enrollment was not sufficient.
eNCIT-Japan
Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma
Sponsor study identifier
interventional
13
1 country
1
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary endpoint of this study is progression-free survival (PFS), with secondary endpoints of anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
July 16, 2007
Actual (reported)July 18, 2007
Actual (reported)August 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
progression-free survival
6 months
Anticancer effect, time to treatment failure (TTF), QOL (FACT-BRM), compliance, adverse drug reactions and immunological factors
6 months
S-1 plus PSK group
S-1 alone
S-1 80mg/m2 4weeks on 2 weeks off, PSK 3g/day
S-1 80mg/m2, 4weeks on followed by 2 weks off
Shizuoka Cancer Center
Shizuoka, Shizuoka, 411-8777, Japan
Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.
Hideaki Tahara, MD
Eastern Network of Cancer Immunological Therapy, Japan
13 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2007
First Posted
July 18, 2007
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 23, 2009
Record last verified: 2009-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: